Specialist, Pharmacovigilance, Icsr

At Johnson Johnson we believe health is everything Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented treated and cured where treatments are smarter and less invasive and solutions are personal Through our expertise in Innovative Medicine and MedTech we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity Learn more at https www jnj com Job Function Product Safety Job Sub Function Pharmacovigilance Job Category Scientific Technology All Job Posting Locations Hyderabad Andhra Pradesh India Job Title Specialist Pharmacovigilance ICSR About the Role Join a global pharmacovigilance team transforming case management through smarter data-driven solutions The Specialist Pharmacovigilance ICSR Capabilities helps design implement and sustain innovative process and technology improvements across Global Case Management This position combines scientific and operational expertise to enhance efficiency compliance and data quality in patient safety reporting Key Responsibilities Lead and support the design deployment and continuous improvement of ICSR capabilities and tools including automation AI-based and data-driven solutions Collaborate with Case Management and cross-functional partners to ensure operational readiness adoption and compliant integration of new capabilities Drive governance training and performance monitoring frameworks that keep capabilities reliable effective and inspection-ready Apply pharmacovigilance expertise to evaluate data accuracy and process alignment Partner with system and process owners to identify gaps propose corrective actions and implement sustainable improvements Support core case-management operations by providing input and validation for protocol-related or capability-linked activities ensuring operational readiness and compliance Design and execute structured case-testing scenarios including the creation of realistic ICSR case scenarios detailed test scripts and validation steps to ensure accurate system behavior data integrity and alignment with end-to-end case management processes Behavioral Competencies Ability to work independently and proactively manage responsibilities in a remote cross-regional environment Strong problem-solving mindset with the ability to understand issues propose solutions and escalate appropriately Collaborative team spirit with a genuine commitment to shared success constructive communication and respectful partnership with colleagues across sites and time zones High professionalism including reliability accountability and a consistent focus on quality and compliance Positive solution-oriented attitude with the ability to navigate ambiguity and adapt to evolving priorities Required Qualifications Bachelor s or Master s degree in Life Sciences Pharmacy Medicine Nursing or a related discipline 5-8 years of experience in pharmacovigilance case management or related regulated operations Deep understanding of the ICSR lifecycle intake processing reporting and PV concepts seriousness causality expectedness MedDRA Experience contributing to process improvement AI or automation initiatives or workflow optimization in a regulated environment Experience designing writing and executing test scripts or case-testing scenarios to validate system functionality and data accuracy Strong analytical communication and collaboration skills Fluency in English written and spoken Preferred Qualifications Experience with safety systems e g ArisGlobal LifeSphere Oracle Argus or similar Familiarity with automation innovation e g GenAI Understanding of metrics and continuous-improvement methodologies Proven ability to operate effectively in a dynamic evolving environment Required Skills Preferred Skills Analytical Reasoning Clinical Operations Coaching Collaborating Cross-Functional Collaboration Detail-Oriented Pharmacovigilance Quality Control QC Quality Management Systems QMS Regulatory Affairs Management Report Writing Root Cause Analysis RCA Safety Investigations Safety-Oriented Serious Adverse Event Reporting Technologically Savvy